510(k) K123630

FRESENIUS LIBERTY CYCLER by Fresenius Medical Care North America, Design Cente — Product Code FKX

K123630 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care North America, Design Cente for the device "FRESENIUS LIBERTY CYCLER". The FDA issued a decision of Substantially Equivalent on September 9, 2013. The device falls under product code FKX (System, Peritoneal, Automatic Delivery), a Class II device regulated under 21 CFR 876.5630. Fresenius Medical Care North America, Design Cente has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2013
Date Received
November 23, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Peritoneal, Automatic Delivery
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type